TriangleNCT04487106 · OUTCOME
Relapse-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From documented CR/CRi until relapse or death, assessed until study completion
What was measured
Relapse-free survival is the time from documented CR/CRi until relapse or death.
Groups in this outcome
Cohort A (Newly Diagnosed AML Patients)
INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)
INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
| Group | Source count |
|---|---|
| Cohort A (Newly Diagnosed AML Patients) | 3 |
| Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Newly Diagnosed AML Patients) | 19 | Not reported | 5.6 | 32.3 | Not reported |
| Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients) | NA | Not reported | 31.0 | 34.6 | Within the study's follow-up period, less than half of the patients have experienced relapse, so a median RFS hasn't been statistically determined |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 32.3
- value
- 19
- comment
- Within the study's follow-up period, less than half of the patients have experienced relapse, so a median RFS hasn't been statistically determined
- group Id
- OG001
- lower Limit
- 31.0
- upper Limit
- 34.6
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Relapse-free survival is the time from documented CR/CRi until relapse or death.
- dispersion Type
- Full Range
- groups
- description
- INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
- id
- OG000
- title
- Cohort A (Newly Diagnosed AML Patients)
- description
- INDUCTION (CYCLE 1): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-28, and trametinib PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION (CYCLES 2-24): Patients receive azacitidine IV over 30-60 minutes or SC on days 1-7, venetoclax PO QD on days 1-21, and trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Trametinib: Given PO Venetoclax: Given PO
- id
- OG001
- title
- Cohort B (Relapsed/Refractory AML or Higher-risk MDS or CMML Patients)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From documented CR/CRi until relapse or death, assessed until study completion
- title
- Relapse-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice